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LEPONEX - LEPONEX - CT 8954 - Version anglaise

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Présentation LEPONEX 100 mg, comprimé sécable B/14 - Code CIP : 3551404 B/28 - Code CIP : 3551410 LEPONEX 25 mg, comprimé sécable B/14 - Code CIP : 3551350 B/28 - Code CIP : 3551367 B/7 - Code CIP : 3551344 Mis en ligne le 19 mars 2013 Substance active (DCI) clozapine Progrès thérapeutique modéré dans le traitement de la schizophrénie Six antipsychotiques de seconde génération (ASG) ont l'AMM dans la schizophrénie : ABILIFY (aripiprazole), LEPONEX et génériques (clozapine), RISPERDAL et génériques (rispéridone), SOLIAN et génériques (amisulpride), XEROQUEL (quétiapine) et ZYPREXA et génériques (olanzapine).Les ASG constituent une classe hétérogène en termes d’efficacité et de tolérance. Cependant, les données ne permettent pas de privilégier un ASG plutôt qu’un autre. Code ATC N05AH02 Laboratoire / fabricant Laboratoire NOVARTIS PHARMA S.A.S. LEPONEX 100 mg, comprimé sécable B/14 - Code CIP : 3551404 B/28 - Code CIP : 3551410 LEPONEX 25 mg, comprimé sécable B/14 - Code CIP : 3551350 B/28 - Code CIP : 3551367 B/7 - Code CIP : 3551344 Mis en ligne le 19 mars 2013

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Published 30 November 2011
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Language English
 
 
 
 
The legally binding text is the original French version 
TRANSPARENCY COMMITTEE
OPINION  
 30 November 2011   Examination of the dossier for proprietary medicinal products included for a 5-year period starting on 30 June 2006 (Official Gazette of 3 October 2007)  LEPONEX 25 mg, scored tablets B/7 (CIP code: 355 134-4) B/14 (CIP code: 355 135-0) B/28 (CIP code: 355 136-7)  LEPONEX 100 mg, scored tablets B/14 (CIP code: 355 140-4) B/28 (CIP code: 355 141-0)   Applicant: NOVARTIS PHARMA S.A.S.  Clozapine  ATC code: N05AH02  List I Medicine for restricted medical prescription. Initial annual hospital prescription restricted to psychiatry, neurology or geriatrics specialists. May be renewed by psychiatry, neurology or geriatrics specialists. Medicine requiring special monitoring during treatment. The doctor should state on the prescription that a white blood cell count has been performed (date) and that the levels observed are within normal limits, and he should update the monitoring booklet provided by the marketing authorisation holder to the hospital pharmacist.  Date of Marketing Authorisation (mutual recognition): 20 June 1991  Reason for request: Re-assessment of the Actual Benefit and Improvement in Actual Benefit in accordance with article R-163-21 of the Social Security Code. Renewal of inclusion on the list of medicines refundable by National Health Insurance.  Therapeutic indications: “LEPONEX is indicated in treatment-resistant schizophrenic patients and in schizophrenia patients who have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical antipsychotics. Treatment resistance is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two different antipsychotic agents, including an atypical antipsychotic agent, prescribed for adequate duration.  
 
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